European Public Assessment Report summary paper version: original (round 1) and revised (round 2)
Original (round 1) | Revised (round 2) | |||
---|---|---|---|---|
Questions | Number of points found/understood | Target met? | Number of points found/understood | Target met? |
1 Who has this report been written for? | 7 / 7 | No | 8 / 8 | No |
2 When is Bondronat used in breast cancer? | 9 / 4 | No | 10 / 7 | No |
3 What is the purpose of this report? | 7 / 0 | No | 9 / 9 | Yes |
4 What can the tablets do to the food pipe? | 10 / 0 | No | 10 / 10 | Yes |
5 Who made the decision about Bondronat described in this report? | 10 / 1 | No | 9 / 9 | Yes |
6 What group of medicines does Bondronat belong to? | 7 / 7 | No | 10 / 10 | Yes |
7 What did Committee for Medicinal Products for Human Use (CHMP) decide about Bondronat? | 10 / 10 | Yes | 10 / 10 | Yes |
8 The tablets can irritate the food pipe. Which people cannot have the tablets as a result of this? | 9 / 8 | Yes | 10 / 8 | No |
9 What two things were weighed up before decision made about whether Bondronat should be approved? | 7 / 7 | No | 10 / 10 | Yes |
10 How does Bondronat prevent fractures, or broken bones? | 10 / 9 | Yes | 8 / 7 | No |
11 In the studies looking into bone problems or complications, what was looked at to see if Bondronat was working? | 5 / 4 | No | 10 / 9 | Yes |
12 During the studies into high calcium levels, how many people did the 4 mg dose work in? | 9 / 9 | Yes | 10 / 10 | Yes |
13 How many people receiving a Bondronat infusion got a fever? | 10 / 3 | No | 10 / 8 | No |
14 During the study of bone complications, what was Bondronat compared with? | 9 / 9 | Yes | 10 / 10 | Yes |
15 Suppose you want more information on how the decision was made about Bondronat, what should you do? | 9 / 1 | No | 10 / 9 | Yes |
16 How many people taking the Bondronat tablet got an inflamed food pipe? | 10 / 5 | No | 10 / 9 | Yes |
17 In the research studies of high calcium levels in the blood, what was Bondronat compared against? | 9 / 9 | Yes | 9 / 9 | Yes |
18 When Bondronat was studied in the treatment of bone complications, which group of patients got a new bone problem first? | 8 / 8 | No | 9 / 9 | Yes |
19 If you are a patient and want more information about Bondronat, what should you do? | 8 / 7 | No | 10 / 10 | Yes |
Total number of passes | 6 | 14 |